Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects

Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.

Study Overview

• Status: Unknown
• Conditions: Periodontal Diseases

Detailed Description

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Jaideep Mahendra, MDS;PhD; Phone Number: 9444963973; Email: jaideep_m_23@yahoo.co.in
• Study Contact Backup: Name: Daliah Ruth, BDS; Phone Number: 9789772881; Email: daliah02ruth@gmail.com

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600095
      • Recruiting
      • Jaideep Mahendra
      • Contact: Jaideep Mahendra, MDS;PhD; Phone Number: 9444963973 9444963973; Email: jaideep_m_23@yahoo.co.in
      • Contact: Daliah Ruth, BDS; Phone Number: 9789772881; Email: daliah02ruth@gmail.com
      • Principal Investigator: Daliah Ruth, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients within the age group of 35-60 years. The subjects were from the South Indian population.

Description

Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients within the age group of 30-65 years (both male and female)
3. Patients should have ≥ 10 natural teeth.

4. Criteria for selection of generalized chronic periodontitis:

   • Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.

5. Criteria for selection of type II diabetes mellitus:

   • Patients having HbA1C <7

Exclusion Criteria:

1. Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
2. Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
3. Current smokers, individuals who quit smoking less than 6 months.
4. Patients who had undergone periodontal therapy within the previous 6 months.
5. Pregnant women (which may alter the oral flora).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group I; Group I :40 Generalized chronic periodontitis subjects without type II diabetes mellitus
Group II; Group II: 40 Generalized chronic periodontitis subjects diagnosed with type II diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of CD163 gene	Expression of CD163 gene using RT-PCR	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the levels of CD163	Quantify the levels of CD163 using ELISA	12 months

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Study Director: Jaideep Mahendra, MDS,PhD, Meenakshi Ammal Dental College

Publications and helpful links

General Publications

• Detzen L, Chen SCY, Cheng B, Papapanou PN, Lalla E. Increased levels of soluble CD163 in periodontitis patients. J Clin Periodontol. 2017 Jun;44(6):585-590. doi: 10.1111/jcpe.12731. Epub 2017 May 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 15, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: CD163, Chronic periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: MADC/IRB-XV/2017/302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No